The US Food and Drug Administration (FDA) became a central focus of the nation and world’s attention in 2020, since the agency regulates many of the critically needed therapies, treatments, and interventions needed to mitigate and combat the COVID-19 pandemic. The agency faced many challenges in light of the inevitable politicization of a public health emergency, exercising rarely used authorities to facilitate an expedient response to the pandemic, in addition to pushing forward its traditional regulatory agenda.

We review notable actions that shaped FDA-regulated industries and products in 2020 and offer insights into the agency’s 2021 expected actions and priorities in the following areas:

  • COVID-19 Response
  • Drugs and Biologics
  • Medical Devices
  • Digital Health
  • Laboratory-Developed Tests And Precision Medicine
  • Food
  • Dietary Supplements
  • Tobacco
  • Cannabis
  • Clinical Investigations
  • Advertising and Promotion
  • Enforcement